Eshghpour 2014.
Study characteristics | ||
Methods | Study design: double‐blinded, randomised clinical trial, split‐mouth technique Conducted in: Iran |
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Participants | Inclusion criteria: 18 to 35 years of age, have American Society of Anesthesiologists physical status I or II; have bilateral mandibular third molars; have the same difficulty level of bilateral third molars based on the Pederson classification Exclusion criteria: pericoronitis of the mandibular third molar(s), received antibiotic regimen during the previous 2 weeks, had a smoking habit, was lactating or pregnant, was using oral contraceptives, had any lesions found on the panoramic radiograph, had any complications during extractions, or had received more than 2 anaesthetic cartridges during surgery Number randomised: 85 Number evaluated: 78 (bilateral impacted teeth) (33 male and 45 female; mean age 25.09 years) |
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Interventions | Comparison: placement of PRF versus none in the extracted socket PRF was placed in 1 of the sockets, and the other socket received no treatment. Group A intervention (n = 78) Group B control (n = 78) Note: postoperative prescriptions were amoxicillin (500 mg 3 times daily, n = 21) and paracetamol (500 mg 3 times daily, for a maximum of 3 days) |
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Outcomes | Alveolar osteitis at days 2 and 7 Based on the c2 analysis, the frequency of alveolar osteitis had a significant association with the application of PRF. Sockets that received PRF after extraction had a statistically significant decreased risk of developing alveolar osteitis compared with non‐PRF sockets (risk ratio 0.44, 95% confidence interval 0.148 to 0.989; P = 0.042). |
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Notes | Descriptive statistics (frequency, mean, and standard deviation) were determined for each variable. Data analysis was performed with c2 and t tests using SPSS 11.5 (SPSS Inc, Chicago, IL), with a confidence interval of 95%. Sample size calculation: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "PRF was randomly inserted into one of the sockets" Comment: coin toss technique was used to decide which side received intervention or control |
Allocation concealment (selection bias) | Unclear risk | Comment: not clear whether randomisation of participants was done by someone different from the person who recruited participants |
Blinding (performance bias and detection bias) patient | Unclear risk | Quote: an operator blinded to the surgery performed the PRF insertion and suturing. Hence, the participants and the surgeon were blind to the side in which PRF had been inserted. Comment: all participants had blood taken and PRF placed. However, a new surgeon coming in to work on one side of the mouth would reveal which side the PRF went into. |
Blinding (performance bias and detection bias) assessor | Low risk | Quote: "the randomisation data were kept unknown by another investigator until the end of the study" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "eighty‐five patients met the inclusion criteria and entered the study; however, 6 patients received more than 2 anesthetic cartridges and 1 female patient had used oral contraceptives during the first postoperative week (as emergency birth control). Therefore, 78 patients (33 male and 45 female; mean age, 25.09 Æ 4.25 yr) completed the study" Comment: 85 participants were recruited, and the outcomes of 78 were reported. Justification for this was provided. |
Selective reporting (reporting bias) | Low risk | Planned outcomes were reported. |
Other bias | Low risk | No other sources of bias identified. |